Abstract: Methods and systems for accessing, maintaining, analyzing, and visualizing structured data are presented. The system receives from a requesting computing device, a first request for a first hierarchical record. The system searches a first repository having first structured data. The system determines whether the first hierarchical record is present in the first structured data and creates, based on the first hierarchical record, a snapshot query criterion. The system then searches, based on the snapshot query criterion, a second repository comprising a first snapshot of the first structured data. The system determines whether a second hierarchical record at least partially matches the first hierarchical record.

Abstract: A method for executing a query on column-orientated repository includes receiving a plurality of case data records including case data. The method includes restructuring the case data of the plurality of data records from a first data structure to a column-oriented data structure. The case data is restructured such that each case data record of the plurality of case data records is maintained in the restructured case data. The method includes storing the restructured case data in a column-oriented repository. The method includes selecting a query template from a first repository. The query template defines a query. The method includes executing the query of the query template on the column-oriented repository to select a portion of the restructured case data stored in the column-oriented repository. The method further includes generating a digital file based on the selected portion of the restructured case data. The method further includes outputting digital file.

Abstract: Systems and methods for optimized processing of global regulatory submissions to health authorities. A content management system provides an end-to-end solution for submitting regulatory documents, from authoring through uploading to a health authority gateway. The content management system creates, manages and consigns submission content plans for a regulatory event requiring regulatory approval based on a global content plan. The content plans may be generated based on content plan templates which may take into account submission information and can be dispatched separately by sections, components, or groupings. The global and local submission plans are collated to generate a comparison. A comparison viewer user interface displays the side by side hierarchical comparison of global with submission content plan where each row is a content plan item with differences highlighted.

Abstract: Systems and methods for duplicating data in a data management system. As data is being updated in the data management system, a copy of the updated data is being written to a table for collecting the data changes. The data changes are flattened by a flattener to generate one or more flat files. A packaging controller may package the one or more flat files and generate a data change file. A listing API may list the data change files that are available. The data change file may be accessed via a data access API.

Abstract: System and method for asynchronous remote signature, including a system and method for processing a remote sample request and remote consent. Call reports are generated which enable users to capture data and make edits to detailing and sampling information unique to each HCP in a call with a user. Business card replies, or sample requests, require signature authorization from the HCP. A time-restricted asynchronous remote signature link is sent to the HCP and provides an interface for signature input without requiring the user to be concurrently engaged in the session. BCR entries are locked while the signature request is pending.

Abstract: The disclosed method includes: initializing an optimization computing model; determining a training dataset; applying the training dataset to the optimization computing model to generate a trained optimization computing model; determining a second dataset; in response to applying the second dataset to the trained optimization computing model, initiating display of the optimization indicator on a first graphical display device; determining, based on the optimization indicator, a degree or rate of transition of at least one data element of the second dataset within a temporal window; determining, based on the degree or rate of transition, operational data; enabling modification of the operational data; and initiating transmission of the modified operational data to a second graphical display device via at least one of: a first application associated with a secure storage network, or a second application that is not associated with the secure storage network.

Abstract: A method for determining a potential signal includes receiving a request for case data and a statistical value minimum. The method further includes selecting the case data from the central case warehouse based on the request and determining a statistical value based on the case data. The statistical value is at least one of: a case count, a proportional reporting ratio (PRR) value, a chi-squared value, an Empirical Bayes (EB) value, or an Interaction Singal Score (INTSS) value. The method further includes determining the potential signal associated with a specific adverse event code and a medical product identifier based on the statistical value and the statistical value minimum. The method further includes outputting the statistical value and the potential signal via the secure network.

Abstract: A method for determining and indicating expectedness of an adverse event. The method includes receiving adverse event data associated with the adverse event. The method further includes determining an electronic reference document associated with the clinical study. The method further includes selecting the electronic reference document including a defined adverse reaction from the document repository. The defined adverse reaction includes an active start date. The method further includes generating a case dataset including at least a portion of the adverse event data. The method further includes determining the expectedness of the adverse event based on the defined adverse reaction of the electronic reference document and the adverse event data. The method further includes determining a submission timeframe associated with the case dataset based on the expectedness of the adverse event.

Abstract: A computer-implemented method for quarantine preservation of outcome assessment data integrity in data management systems. The data management system receives an outcome assessment successfully completing a first set of client-side validations, wherein the first set of client-side validations include a series of validations checking for required fields and format checks. A second set of server-side validations is executed including a series of validations checking for uniqueness constraints, complex business rules, cross-referencing with other database records, and consistency. When one server-side validation in the second set of server-side validations fails, the outcome assessment successfully completing the first set of client side validations in a quarantine repository is stored and updated to quarantined state. The outcome assessment is modified to correct the failed server-side validation and subsequently validated a second time.

Abstract: A method for generating location data including receiving and outputting first location data. The method further includes receiving a response and validating the first piece of location data based on the response. The method further includes cleaning the first location data. The method further includes querying a first repository to select second location data and a third location data. The method further includes assigning the cleaned first location data a first rank, the second location data a second rank, and the third location data a third rank. The method further includes merging the cleaned first location data and the second piece of location data to generate first merged location data. The method further includes merging the first merged location data and the third location data to generate second merged location data. The method further includes storing the second merged location data in the first repository.

Abstract: A method for executing sets of code in isolated runtime environments includes selecting a platform package from a platform repository. The platform package includes platform code and a first code library. The method includes selecting a platform bundle from the platform repository. The platform bundle includes a first stylesheet library. The method includes selecting a tenant package from a tenant repository. The tenant package includes platform code and a second code library. The method includes selecting a tenant bundle from the tenant repository. The platform bundle includes a second stylesheet library. The method further includes transmitting the page file, the tenant package, the tenant bundle, the platform package, and the platform bundle to a user computing device. The platform code is executed in isolation of the tenant code, and the tenant code is executed in isolation of the platform code.

Abstract: A method for reconciling differences between a first repository and a second repository includes receiving a request to generate a network connection between the first repository and the second repository. The first repository is associated with the first application, and the second repository is associated with a second application. The method further includes receiving structured data and storing the structured data in the first repository. The method further modifying the structured data to encrypt the structured data. The method further includes providing the encrypted structured data to the second repository. The method further includes receiving updated structured data and storing the updated structured data in the first repository. The method further includes providing the encrypted updated structured data to the second repository.

Abstract: A method for progressing a state of case dataset. The method includes receiving a source file and determining case data based on the source file. The method further includes generating a case dataset. The method further includes selecting a rule including a rule criteria and a sampling ratio. The method further includes determining the sampling ratio of the rule is fulfilled. The method further includes determining, in response to the sampling ratio being fulfilled, the case data of the case dataset fulfills the rule criteria. The method further includes selecting a web form template. The method further includes generating the web form based on the web form template and the case dataset. The method further includes outputting the web form and receiving input data. The method further includes modifying the state of the case dataset from the second stage to a third stage based on the input data.

Abstract: This disclosure is directed to modifying a computing record based on generating and updating a computing report associated with an event. The disclosed method includes: receiving a first source file associated with an event; generating a first computing record based on the first source file; determining, based on the first computing record, a severity indicator, a location, and a computing group; generating a first configuration; executing, based on the first computing record, the first configuration, thereby generating a computing report; modifying, based on the computing report, the first computing record; receiving a second source file associated with the event; generating a second computing record based on the second source file; comparing the first computing record and the second computing record; executing the first configuration or a second configuration, thereby generating an updated computing report; and modifying, based on the updated computing record and the comparing, the first computing record.

Abstract: A computer-implemented method for quarantine preservation of outcome assessment data integrity in data management systems. The data management system receives an outcome assessment successfully completing a first set of client-side validations, wherein the first set of client-side validations include a series of validations checking for required fields and format checks. A second set of server-side validations is executed including a series of validations checking for uniqueness constraints, complex business rules, cross-referencing with other database records, and consistency. When one server-side validation in the second set of server-side validations fails, the outcome assessment successfully completing the first set of client side validations in a quarantine repository is stored and updated to quarantined state. The outcome assessment is modified to correct the failed server-side validation and subsequently validated a second time.

Abstract: A computer-implemented method for quality recurrence check in database management systems. A quality data object record is identified. The database management system establishes a set of match criteria including a temporal constraint, matching field limiter, and text comparison fields restriction. A set of suggested match terms is extracted from a first field in the quality data object record that outline aspects of the quality data object record to be matched. The set of suggested match terms with data object records in the database management system satisfying the set of match criteria are compared to identify potential recurrence data objects associated with the quality data object record. Each identified potential recurrence data object satisfying a threshold is associated with the quality data object. Similarly, the inverse association is executed. The quality data object is associated with each identified potential recurrence data object satisfying the threshold.

Abstract: Embodiments disclosed in the present document provide systems and methods for data management system summary and preview. Definition objects are digitally translated into a linguistic representation to generate a preview transformation of a study. The definition objects are transformed into a study schedule matrix outlining events, outcome assessments, and respondent type. Characteristics of a patient are obtained and used to generate a preview transformation of an outcome assessment for a given event based on the characteristic of the patient as well as additional characteristics defining a device type, aspect ratio, and language. The text in the outcome assessment to the obtained language is translated and transformed based on the obtained device type and aspect ratio. The preview transformation of the outcome assessment is re-generated for the given event based on the additional characteristics.

Abstract: Systems and methods for managing user authentication in a computer network. Users don't need a password or SSO integration. The system may determine the organization the user is associated with by the user's email address, and authenticate the user if the organization is authorized and stored in a storage system previously. The system may add user's information to the storage system. The system may attempt to detect when to de-provision a user by regularly sending a test email to the user's email address, and remove the user's email address from the storage system when the test email bounces.

Abstract: Disclosed is a method, system, and computer program product for using a multisystem data collection computing input tool. Data associated with plurality of sources is received and transformed to be stored in a specialized database and format. Access to the specialized database is enabled over a multisystem network such that a user may view and update the data in real time through a graphical user interface. In some embodiments, updates to data are automatically occurring in real time without user instruction.

Abstract: Systems and methods for generation, categorization and rendering of custom dynamic view layouts of secure customer data of a data storage, including systems and methods for generation and management of multiple view layouts of secure customer data enabled using a view layout profile. Custom dynamic view layouts are established, wherein each custom dynamic view layout corresponds to a data object type and comprises at least one page including one or more sections used to organize a subset of a data object of the data object type from the data storage. Custom dynamic view layouts are assigned to view layout profiles. The view layout profile is referenced to identify a matching object type to the accessed data object record from the data storage. The matching custom view layout is used to render and display the subset of data fields defined in the identified approved custom dynamic view layout.